Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
The U.S. Food and Drug Administration (FDA) on January 2, 2020, issued a policy prioritizing enforcement against flavored e-cigarette products that are manufactured and marketed in a manner that appeal to minors because the are flavored or marketed to taste or look like popular cereals, juices, or candies. Since implementation of the FDA’s premarket authorization
Read MoreFDA’s 510(k) Third-Party Review program benefits the public health by allowing low-to-moderate risk medical devices obtain FDA-equivalent review while enabling FDA to focus more resources on higher risk and more complex devices.
Read MoreU.S. Food and Drug Administration (FDA) issued a Warning Letter to U.S. food importer, B&I Overseas Trading Inc., for failing to implement supplier verification protocols, as required under the “Foreign Supplier Verification Program” (FSVP), to assure that fish imported by the company into the U.S. was produced in accordance with U.S. food safety regulations. In the FDA
Read MoreIn light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has
Read MoreOn June 9, 2016, The U.S. Food and Drug Administration (FDA) announced that it took action against 4,402 websites illegally selling unapproved prescription drugs to U.S. consumers. With the assistance of U.S. Customs and Border Protection, the FDA conducted inspections at International Mail Facilities (IMFs) and served formal complaints on domain registrars “requesting the suspension
Read MoreOn May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical
Read MoreOn May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through
Read MoreThe Food and Drug Administration (FDA) recently issued a final guidance declaring use of the term “evaporated cane juice” (ECJ) on food labeling to be misleading. “Evaporated cane juice” is a term commonly used on food labels to identify the presence of sweeteners derived from the fluid extract of sugar cane. However, FDA’s most recent
Read MoreThe U.S. Food and Drug Administration (FDA) issued a constituent update today explaining its decision to allow KIND, LLC to use “healthy” claims on food labels and labelling, while also vowing to reevaluate regulations regarding nutrient content claims and the labeling of food as “healthy.” Nutrient content claims are those that expressly or implicitly characterizes
Read MoreThe Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products. The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products. Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has
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